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Register to vote Register by 18 June to vote in the General Election on 4 July.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
How to use a patient-reported outcomes and experiences study to evaluate your digital health product.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and information about the publication of two recent Device Safety Information pages. The article also includes information on a recent National Patient Safety Alert...
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
These published standards relate to a number of KPIs in the VMD Deliverables and KPI document.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Guidance for the veterinary pharmaceutical industry on the production and submission of the Summary of Product Characteristics (SPCs) and product literature mock-ups.
If you import, manufacture, process, distribute or sell plant protection products (PPPs) for professional use in Great Britain, register to comply with regulations.
Information on good laboratory, manufacturing and distribution practice, good pharmacovigilance practice (GPvP), out-of-specification investigations, inspection metrics and fees.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
How we evaluated pre-exposure prophylactic (preventative) treatments for COVID-19.
If you’re a business, organisation or sole trader that uses PPPs and adjuvants professionally in Great Britain, register to comply with regulations.
Protocols and procedures for testing the distinctiveness, uniformity and stability (DUS) of certain agricultural and vegetable plants.
Don’t include personal or financial information like your National Insurance number or credit card details.
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